Maalox Plus 200 mg/175 mg/25 mg Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Aluminium hydroxide; Magnesium hydroxide; Simeticone

Available from:

Opella Healthcare France SAS T/A Sanofi

ATC code:

A02AF; A02AF02

INN (International Name):

Aluminium hydroxide; Magnesium hydroxide; Simeticone

Dosage:

200 mg/175 mg/25 mg/5ml

Pharmaceutical form:

Oral suspension

Therapeutic area:

Antacids with antiflatulents; ordinary salt combinations and antiflatulents

Authorization status:

Marketed

Authorization date:

1975-11-10

Patient Information leaflet

MAALOX® PLUS 200MG/175MG/25MG PER 5ML
ORAL SUSPENSION
_magnesium hydroxide _
_aluminium hydroxide _
_simethicone _
_ _
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU
This medicine is available without prescription. However, you still
need to use Maalox Plus Oral
Suspension carefully to get the best results from it.
•
Keep this leaflet. You may need to read it again
•
Ask your pharmacist if you need more information or advice
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet.
•
You must talk to a doctor if you do not feel better or if you feel
worse after taking this medicine.
IN THIS LEAFLET:
1.
What Maalox Plus Oral Suspension is and what it is used for
2.
What you need to know before you take Maalox Plus Oral Suspension
3.
How to take Maalox Plus Oral Suspension
4.
Possible side effects
5.
How to store Maalox Plus Oral Suspension
6.
Contents of the pack and other information
1.
WHAT MAALOX PLUS ORAL SUSPENSION IS AND WHAT IT IS USED FOR
Maalox Plus Oral Suspension contains three different medicines:
•
The first two medicines are called magnesium hydroxide and aluminium
hydroxide. They belong to
a group of medicines called antacids.
•
The other medicines is called simeticone. It belongs to a group of
medicines called anti-foaming
agents.
Maalox Plus Oral Suspension is used for:
•
The relief of indigestion (dyspepsia)
•
Heartburn
•
Wind (flatulence)
Maalox Plus Oral Suspension works by lowering the amount of acid in
your stomach. The anti-
foaming agents in Maalox Plus Oral Suspension helps to remove gas from
your stomach.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAALOX PLUS ORAL SUSPENSION
DO NOT TAKE MAALOX PLUS ORAL SUSPENSION IF:
•
You are allergic (hypersensitive) to magnesium hydroxide, aluminium
hydroxide, simeticone or any
of the other ingredients in Maalox Plus Oral Suspension (see Section
6: Contents of the pack and
other information). Signs of an allergic reactio

Summary of Product characteristics

Health Products Regulatory Authority
15 November 2023
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Maalox Plus 200 mg/175 mg/25 mg Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of the suspension contains:
200 mg of Magnesium Hydroxide (as Magnesium Hydroxide Paste)
175 mg of Aluminium Hydroxide (as Aluminium Hydroxide Gel ),
25 mg of Simeticone.
Excipients with known effect: Each 5ml also contains 224.85 mg
sorbitol (E420), 1.66mg sodium, 3.667mg ethanol, 3ppm
sulphur dioxide (E220) (3ppm)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Suspension
A white lemon flavoured oral suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of heartburn, indigestion, flatulence and dyspepsia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The route of administration is oral.
Recommended Dosage
Adults: One to two x 5ml spoonfuls four times a day (after meals and
at bedtime) or as required.
Children: Not recommended
4.3 CONTRAINDICATIONS
Use in severely debilitated patients or in those suffering from kidney
failure.
Use in patients who are hypersensitive to the active ingredients or to
any of the excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Aluminium hydroxide may cause constipation and magnesium salts
overdose may cause
hypomotility of the bowel; large doses of this product may trigger or
aggravate intestinal obstruction and ileus in patients at
higher risk such as those with renal impairment, infants less than 2
years, or the elderly..
Aluminium hydroxide is not well absorbed from the gastrointestinal
tract, and systemic effects are therefore rare in patients
with normal renal function. However, excessive doses or long-term use,
or evennormal doses in patients with low-phosphorus
Health Products Regulatory Authority
15 November 2023
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Page 2 of 5
diets or in infants less than 2 years, may lead tophosphate depletion
(due to aluminium-phosphate binding) accompanied by
increased boneresorption